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Relyvrio for ALS
The Medical Letter on Drugs and Therapeutics • Nov 28, 2022 (Issue 1664)
earlier.1,2
CLINICAL STUDIES ― FDA approval of Relyvrio
was based on the results of a double-blind phase ...
The FDA has approved Relyvrio (Amylyx), a fixed-dose
combination of sodium phenylbutyrate and
taurursodiol, for treatment of amyotrophic lateral
sclerosis (ALS). Sodium phenylbutyrate (Buphenyl,
and others) has been available by prescription
for years for treatment of urea cycle disorders.
Taurursodiol (tauroursodeoxycholic acid), a derivative
of ursodiol, is an over-the-counter bile acid
supplement claimed to have neuroprotective
benefits. Relyvrio is the third drug to be approved
in the US for treatment of ALS; riluzole (Rilutek, and
others) and edaravone (Radicava, Radicava...
PPIs and Fracture Risk
The Medical Letter on Drugs and Therapeutics • Feb 18, 2013 (Issue 1410)
medical history who were not taking a PPI (RR 1.30,
95% CI 1.19-1.43). Fracture risk was similar ...
Use of proton pump inhibitors (PPIs) to treat gastroesophageal
reflux disease (GERD) has been associated
with an increase in the risk of fractures. The FDA
now requires that the labels of all prescription PPIs
include a warning about an increased risk of fractures
with long-term use.
Safety of Testosterone Replacement Therapy
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016 (Issue 1490)
to evaluate the safety of
testosterone replacement therapy.1
ADVERSE EFFECTS — Testosterone administration ...
Three coordinated double-blind, placebo-controlled
clinical trials have evaluated the efficacy of one year of
testosterone replacement therapy in improving sexual
function, physical function, and vitality in a total of
790 men ≥65 years old with moderately low serum
testosterone concentrations and symptoms suggesting
hypoandrogenism. Sexual function improved
modestly, and there appeared to be marginal benefits
in some areas of physical function and vitality as well.
The trials were not designed to evaluate the safety of
testosterone replacement therapy.
Sugammadex (Bridion) for Rapid Reversal of Neuromuscular Blockade
The Medical Letter on Drugs and Therapeutics • Aug 29, 2016 (Issue 1502)
such as hypotension and bradycardia
can occur.1
PHARMACOLOGY — Sugammadex forms complexes
with rocuronium ...
The FDA has approved sugammadex (Bridion – Merck),
a selective relaxant binding agent, for reversal of
rocuronium- or vecuronium-induced neuromuscular
blockade in adult surgical patients. It is the first
selective relaxant binding agent to be approved in the
US. Sugammadex has been available in the European
Union, Japan, and elsewhere for several years. Previous
FDA reviews of sugammadex did not result in approval
because of concerns about a risk of anaphylaxis and
other hypersensitivity reactions with its use.
Oxymetazoline Cream (Rhofade) for Rosacea
The Medical Letter on Drugs and Therapeutics • May 22, 2017 (Issue 1521)
receptor agonist oxymetazoline as a 1% cream (Rhofade
– Allergan) for topical treatment of persistent ...
The FDA has approved the selective alpha1A-adrenergic
receptor agonist oxymetazoline as a 1% cream (Rhofade
– Allergan) for topical treatment of persistent facial
erythema of rosacea in adults. Brimonidine, a selective
alpha2-adrenergic receptor agonist, was approved in
2013 as a 0.33% gel (Mirvaso) for the same indication.
Like Mirvaso, Rhofade is not indicated for treatment of
inflammatory lesions of rosacea. Oxymetazoline has
been available over the counter for many years as a
nasal decongestant spray (Afrin, and others).
Inhaled Insulin (Exubera)
The Medical Letter on Drugs and Therapeutics • Jul 17, 2006 (Issue 1239)
) has been approved
by the FDA for treatment of adults with type 1 or type 2
diabetes.
DELIVERY — Exubera ...
An inhaled, dry-powder formulation of rapid-acting human insulin (Exubera - Pfizer) has been approved by the FDA for treatment of adults with type 1 or type 2 diabetes.
A 4-Drug Combination (Stribild) for HIV
The Medical Letter on Drugs and Therapeutics • Nov 26, 2012 (Issue 1404)
) emtricitabine and tenofovir disoproxil
fumarate (Stribild – Gilead) for treatment of HIV-1
infection ...
The FDA has approved a fixed-dose combination of
the integrase strand transfer inhibitor (INSTI) elvitegravir,
the pharmacokinetic enhancer cobicistat, and
the nucleoside/nucleotide reverse transcriptase inhibitors
(NRTIs) emtricitabine and tenofovir disoproxil
fumarate (Stribild – Gilead) for treatment of HIV-1
infection in antiretroviral treament-naïve adults.
Elvitegravir is the second INSTI to be approved by the
FDA for use in HIV treatment; raltegravir (Isentress)
was the first.
Clopidogrel (Plavix) Revisited
The Medical Letter on Drugs and Therapeutics • Apr 10, 2006 (Issue 1232)
infarction
(MI), stroke and other vascular events
1
and for use in
patients with acute coronary syndrome ...
Clopidogrel (Plavix - Sanofi-Aventis and Bristol-Myers Squibb), an oral thienopyridine that inhibits platelet aggregation, is now being advertised directly to the public on television. Clopidogrel is approved by the FDA for secondary prevention of myocardial infarction (MI), stroke and other vascular events and for use in patients with acute coronary syndrome (unstable angina or non-ST-elevation MI), including those undergoing angioplasty. It is used off-label for patients with ST-elevation acute MI
Istradefylline (Nourianz) for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Feb 10, 2020 (Issue 1591)
, or
a monoamine oxidase type B (MAO-B) inhibitor.1,2 A
subcutaneous formulation of the nonergot dopamine
agonist ...
The FDA has approved istradefylline (Nourianz —
Kyowa Kirin), an oral adenosine A2A receptor antagonist,
for use as an adjunct to carbidopa/levodopa in adults
with Parkinson's disease (PD) who experience "off"
episodes. Istradefylline is the first adenosine A2A
receptor antagonist to be approved in the US; it has
been available in Japan since 2013.
Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021 (Issue 1615)
clinical trials, opicapone significantly reduced “off” time by
about 1 hour, compared to placebo. In one ...
The FDA has approved opicapone (Ongentys –
Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an
adjunct to carbidopa/levodopa in adults with Parkinson’s
disease (PD) who experience "off" episodes. It is the
third COMT inhibitor to be approved for this indication;
tolcapone (Tasmar, and generics) and entacapone
(Comtan, and generics) were approved earlier. Opicapone
has been available in Europe since 2016.